Pantoprazole and Docetaxel for Men With Metastatic Castration-Resistant Prostate Cancer - a Single Arm Phase II Clinical Trial With a Predefined Reference Group (PANDORA)
Inclusion Criteria:
- Age ≥18yrs
- ECOG performance status ≤2
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Clinical or radiological evidence of metastatic disease
- Disease progression while receiving androgen deprivation therapy with an increase in
PSA of 25% or greater over nadir value measured on 3 consecutive occasions at least 1
week apart
- Antiandrogen therapy must have been stopped at least 4 weeks prior to start of trial
treatment (6 weeks in the case of bicalutamide or nilutamide)if there was a reduction
in serum PSA after this therapy was initiated
- Baseline serum prostate-specific antigen (PSA)≥10ng/ml
- Total testosterone <50 ng/dL (<1.7 nmol/L)
- Adequate hematologic values: neutrophil count ≥1,500/mm3, platelet ≥100,000/mm3,
hemoglobin ≥10.0 g/dl
- Adequate hepatic and renal function: total bilirubin level ≤1.5 x ULN (unless
secondary to documented Gilbert's disease); ALT,AST, and creatinine ≤1.5 x ULN
- Ability to understand and to sign consent for the study
Exclusion Criteria:
- Prior treatment for prostate cancer with chemotherapy or radioisotopes
- History of another cancer within the preceding five years (except basal or
squamous-cell skin cancer or adequately treated superficial bladder cancer)
- Known or suspected brain or leptomeningeal metastases
- Symptomatic peripheral neuropathy of grade 2 or higher
- Major surgery within 4 weeks of start of trial treatment
- Radiotherapy to ≥25% of the bone marrow and any radiotherapy within 4 weeks of start
of trial treatment
- Known hypersensitivity to trial treatment or hypersensitivity to any of its
components
- Any concomitant drugs contraindicated for use with the trial treatment
- Any serious underlying medical condition which could impair the ability of the
patient to participate in the trial
- Any psychological, familial, sociological or other patient related factors that might
preclude compliance with the study protocol